Status:
TERMINATED
A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement
Lead Sponsor:
DePuy International
Conditions:
Rheumatoid Arthritis
Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to monitor the performance of the Summit™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be e...
Eligibility Criteria
Inclusion
- i) Male or female subjects, aged between 18 and 70 years (inclusive).
- ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- iv) Subjects who require primary total hip replacement and are considered suitable for a cementless femoral stem.
Exclusion
- i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- ii) Subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty.
- iii) Women who are pregnant.
- iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
- vi) Subjects who are currently involved in any injury litigation claims.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00208390
Start Date
February 1 2003
End Date
May 1 2012
Last Update
August 4 2016
Active Locations (5)
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1
2. Ruijin Hospital
Shanghai, China
2
3. The University of Hong Kong at Queen Mary Hospital
Pokfulam, Hong Kong
3
1. Ospedale Riuniti Di Bergamo
Bergamo, Italy
4
5. Middlemore Hospital
Auckland, New Zealand